SAN FRANCISCO — Among patients with symptomatic, severe native aortic regurgitation at high surgical risk, the JenaValve Trilogy transcatheter heart valve system (JenaValve Technology) met its primary safety and efficacy endpoints, achieving a 1-year all-cause mortality rate of 7.8%.
New pacemaker implantation was 24%, similar to previously reported outcomes.
Vinod Thourani, MD, Piedmont Heart Institute in Atlanta, presented initial outcome results of the ALIGN-AR trial here at Transcatheter Cardiovascular Therapeutics (TCT) 2023.
Thourani concluded that the Trilogy system provides the first dedicated transcatheter aortic valve replacement options "for symptomatic patients with moderate to severe or severe aortic regurgitation or at high risk for surgery and is well positioned to become the preferred therapy upon approval for this population."
Currently, Trilogy is not approved by the US Food and Drug Administration in the United States and is for investigational use only.
Untreated, severe symptomatic aortic regurgitation (AR) is associated with high mortality, especially for those with NYHA class 3 or 4 symptoms, Thourani explained. "While surgery remains the only recommended intervention for patients with native severe AR, there are a multitude of high-risk patients who are not offered therapy."
Off-label use of transcatheter valves for AR has been associated with "higher rates of complications, including paravalvular regurgitation and embolization," he noted.
